Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer

Anandasabapathy, Sharmila, M.D.

Status and phase: Completed; Early Phase 1

Conditions: Squamous Cell Cancer

Treatments: Drug: proflavine

Study type: Interventional

Funder types: Other

Identifiers

NCT01384708

GCO# 10-0982

Details and patient eligibility

About

The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides > 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• known or suspected squamous cell neoplasia
• 18 years or older

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

treatment

Experimental group

Description:

imaging with proflavine

Treatment:

Drug: proflavine